Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02004067|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Sjogren Syndrome Secondary Sjogren Syndrome Aqueous Deficient Dry Eye Disease Evaporative Dry Eye Disease||Drug: Restasis Drug: Refresh Endura||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: Refresh Endura
Topical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months.
Drug: Refresh Endura
Refresh Endura is a topical lubricant produced by Allergan, Inc.
Other Name: Castor oil
Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months
Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
Other Name: Cyclosporine 0.05%
- Ocular surface inflammation [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004067
|Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP|
|Sao Paulo, SP, Brazil, 04023 062|
|Principal Investigator:||Rossen M Hazarbassanov, PhD||Federal University of São Paulo|